Bioequivalence and Bioavailability Forum • FDA: Size of bio-batch

FDA: Size of bio-batch [Regulatives / Guidelines]

posted by jag009 – NJ, 2013-12-10 21:03 (4149 d 15:37 ago) – Posting: # 12032
Views: 13,499
(edited on 2013-12-11 16:21)

Hi Helmut,

❝ Do you know of a corresponding requirement by the FDA? In the Summary Table 11 sizes of the bio-batch and production batch have to be reported.

We always make > 100,000 tablets. See page 2 of FDA Guidance I know it's old...

Hope that helps...

John

Complete thread:

FDA: Size of bio-batch Helmut 2013-12-10 14:05 [Regulatives / Guidelines]
- FDA: Size of bio-batchjag009 2013-12-10 20:03
  - FDA: antique of ’93 Helmut 2013-12-10 23:32
    - FDA: antique of ’93 jag009 2013-12-11 15:23
      - FDA: antique of ’93 Helmut 2013-12-11 15:26
        
        FDA: antique of ’93 jag009 2013-12-11 16:21
        
        FDA: antique of ’93 Helmut 2013-12-11 16:29
        
        FDA: antique of ’93 jag009 2013-12-11 23:16
        
        Patience Helmut 2013-12-12 14:34
    - FDA: antique of ’93 Beholder 2018-06-21 09:21
      - Nice numbers Helmut 2018-06-21 15:05
        
        Nice numbers Beholder 2018-06-22 10:33
        
        Type II variation Helmut 2018-06-22 15:12
      - Birdsong's third law of BE ElMaestro 2018-06-22 10:10
        
        Experience Beholder 2018-06-22 11:04
        
        Why, oh why? Helmut 2018-06-22 15:17
        
        Sorry for the delay Beholder 2018-10-18 09:40

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